Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 7:27 AM
Study NCT ID:
NCT03394950
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2018-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke
Sponsor:
Hui-Sheng Chen
Organization:
Study Overview
Official Title:
Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke (BRAIS)：a Pilot, Prospective, Random, and Double Blinded Multi-center Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunctional prognosis of thrombolytic patients has been a hot topic in the world.
Butyl phthalide is type I chemical drugs. Some multicenter randomized, double-blind, placebo-controlled clinical trials have showed that acute ischemic stroke patients taking butyl phthalide has better lateral branch circulation and living ability score than patients taking placebo. Besides, butyl phthalide treatment is safe. The animal experiment indicated that buphthalein could significantly improve secondary side branch circulation, recover the microarterial diameter of the soft meninges in the ischemic region and increase the blood flow rate.
Based on the discussion, we assume that: giving butyl phthalide to patients with acute ischemic stroke in advance, might promote and improve the formation of collateral circulation to freeze ischemia penumbra. Based on this hypothesis, we would like to explore the efficacy and safety of butyl phthalide combined with rtPA thrombolysis in the treatment of acute ischemic stroke.
Butyl phthalide is type I chemical drugs. Some multicenter randomized, double-blind, placebo-controlled clinical trials have showed that acute ischemic stroke patients taking butyl phthalide has better lateral branch circulation and living ability score than patients taking placebo. Besides, butyl phthalide treatment is safe. The animal experiment indicated that buphthalein could significantly improve secondary side branch circulation, recover the microarterial diameter of the soft meninges in the ischemic region and increase the blood flow rate.
Based on the discussion, we assume that: giving butyl phthalide to patients with acute ischemic stroke in advance, might promote and improve the formation of collateral circulation to freeze ischemia penumbra. Based on this hypothesis, we would like to explore the efficacy and safety of butyl phthalide combined with rtPA thrombolysis in the treatment of acute ischemic stroke.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: